R2 Dermabrasion Tip (for Dermal Cooling System)— 510(k) K203006

Name: FDA 510(k) clearance K203006
Creator: U.S. Food and Drug Administration
Published: 2021-08-05

Substantially Equivalent

R2 Technologies, Inc.

FDA 510(k) clearance K203006 for R2 Dermabrasion Tip (for Dermal Cooling System), Substantially Equivalent on 2021-08-05. Applicant: R2 Technologies, Inc.. Device class: 2.

Clearance details

Applicant: R2 Technologies, Inc.
Product code: Code QPZ
Device class: Class 2
Regulation: 21 CFR 878.4340
Advisory panel: General, Plastic Surgery
Date received: 2020-10-01
Decision date: 2021-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

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